[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100084660":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":11,"locations":44,"responsibleParty":56,"collaborators":11,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":11,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":11,"enrollmentInfo":68,"targetDuration":11,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":80,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"RECORDATI GROUP","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Silodosin","EXPERIMENTAL",null,[13],"Drug: Silodosin",{"label":15,"type":16,"description":11,"interventionNames":17},"Tamsulosin","ACTIVE_COMPARATOR",[18],"Drug: Tamsulosin",{"label":20,"type":21,"description":11,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR",[23],"Drug: Placebo",[25,31,36],{"type":26,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","8 mg daily for 12 weeks",[9],[30],"KMD3213",{"type":26,"name":15,"description":32,"armGroupLabels":33,"otherNames":34},"0.4 mg daily for 12 weeks",[15],[35],"Omnic",{"type":26,"name":20,"description":37,"armGroupLabels":38,"otherNames":11},"once daily for 12 weeks",[20],[40],{"name":41,"affiliation":42,"role":43},"Christopher Re Chapple, BSc MD","Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital","PRINCIPAL_INVESTIGATOR",[45],{"facility":42,"status":11,"city":46,"state":11,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":11},"Sheffield","S10 2JF","United Kingdom","UK",{"type":51,"coordinates":52},"Point",[53,54],-1.4659,53.38297,{"lat":54,"lon":53},{"type":11,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":57,"oldOrganization":58},"Senior Clinical Project Leader","Recordati Industria Chimica e Farmaceutica S.p.A.","100084660","phase-3-evaluation-of-the-efficacy-and-safety-of-silodosin-in-the-treatment-of-the-signs-and-symptoms-of-bph-100084660",false,"NCT00359905","Evaluation of the Efficacy and Safety of Silodosin in the Treatment of the Signs and Symptoms of BPH","Evaluation of the Efficacy and Safety of Silodosin vs. Tamsulosin and Placebo in the Treatment of the Signs and Symptoms of BPH. Multicentre, Randomised, Double-Blind, Controlled Trial With an Optional Long-Term, Open-Label Extension Phase.","Inclusion Criteria:\n\n* Males in good general health and at least 50 years of age, with symptoms of moderate to severe Benign Prostatic Hyperplasia\n\nExclusion Criteria:\n\n* Medical conditions that would confound the efficacy evaluation\n* Medical conditions in which it would be unsafe to use an alpha-blocker\n* Use of concomitant drugs that would confound the efficacy evaluation\n* Use of concomitant drugs that would be unsafe with this alpha-blocker","MALE","50 Years",{"count":69,"type":70},1228,"ACTUAL","INTERVENTIONAL",[73],"PHASE3","A new drug for the treatment of benign prostatic hyperplasia is compared with placebo and tamsulosin (a drug belonging to the same therapeutic class) for to determine if it is safe and effective (the first phase of the study lasts approximately 18 weeks) and then is used for another 9 months to determine its long-term safety.",[76],"Benign Prostatic Hyperplasia",[78,79],"Benign prostatic hyperplasia","alpha-blockers","COMPLETED","2009-02-18",{"date":83,"type":84},"2009-02-19","ESTIMATED",{"date":86,"type":11},"2006-05",{"date":88,"type":70},"2008-01",{"name":5,"class":6},1]